Our clinical group has extensive experience in designing and developing medical technologies. We have the capabilities to offer a complete clinical testing and verification pathway from production ready prototype to acute and chronic animal experiments to first in man and feasibility clinical trials with the highest clinical research standard. We are familiar with the regulatory pathways and its overall impact in bringing a product to market.

The core of our development process is a systematic roadmap to identify, strategize and execute need-driven, value-based medical innovations. We customize our process around specific project needs to achieve maximum efficiency, efficacy and cost savings to deliver a successful product.

Interventional Concepts has the ability to support medical innovators in the following areas of its medical device product development:

1. Project Planning

The Planning Phase is composed of plans and strategies that validate and address the need identified by the innovator. The plans and strategies will serve as an organized roadmap for the Development and Delivery Phases.

Objective:

To validate and address the need identified by the innovator

Deliverable: Project Plan Report

A clear and concise report will be generated including all the elements needed for the development of a medical device that is successful clinically, commercially viable, technically feasible and meets regulatory requirements. The elements are separated in sections in order to sequentially validate the need and address it. Please see Appendix I for additional details.

2. Investor Presentation

Integrating the components within the Planning Phase will yield a clear and concrete “pitch” plan that will explain the innovators vision and compel investors, partners and employees to invest in the project.

Objective:

To prepare innovators to present and defend the opportunity to potential investors and partners.

Deliverable: Investor Presentation

A slide presentation will be generated including topics required to convey the opportunity and address typical investor requirements. Please see Appendix II for additional details.

3. Clinical

We will focus on gathering the technical requirements that are generally required for submission to the different regulatory bodies. Our goal will be to compile a dossier for submission to Colombia's INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) so that a first-in-human clinical study is conducted in a qualified clinical research center in Colombia.

Objective:

To demonstrate the device's safety and efficacy in humans, and as a result, generating clinical and commercial value.

Are the business relationships between referral sources, purchasers, providers, and consumers well understood?

Does the company have a strong competitive position?

Is the technology/service consistent with market, regulation, and reimbursement trends?

Management team

Is the management team smart? Are they knowledgeable about this business?

Does the management team have a proven record, particularly in this business?

Do managers have high levels of honesty and integrity? Can they be trusted?

Do they have reasonable expectations for the business, particularly for the difficulties of product/service development, rate of company growth, capital requirements, ultimate business size and profitability?

Business model and financial requirements

What are realistic revenue and expense projections for the company?

How much capital will be required to reach positive cash flow?

What are realistic expectations for the timing and sources of this cash?

What are the realistic exit opportunities for investors in this deal?

Exit scenarios

How are investors most likely to realize an exit? What scenario seems most likely?

For acquisition candidates, what companies are most likely to be interested? What other acquisitions have the made recently? Does the company have an established relationship with one or more of these companies? Why would these companies acquire a technology in the space rather than developing it themselves?

What timeline is most realistic for achieving an exit?

What are the major factors likely to influence whether or not the exit is realized?

Valuation and deal structure

Will the valuation of the investment in this deal afford a high probability of substantial return (40 percent or greater internal rate of return)?

Will the deal allow for enough capital to be put to work to make the investment worth the time and effort?

Who will be the co-investors? Are these parties good to work with?

How can this investment be structured to minimize the technological and financial risk?

Business planning and teams

What will be the equity ownership of each of the founders?

How will equity and stock options be distributed to key employees?

What is the process through which these decisions will be made?

What will be the responsibilities of the founders and early employees?

What roles will the founder and early employees play as the company evolves and grows?

Who will be the CEO (and will they be an interim CEO to be replaced by a permanent CEO)?